DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
1. A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on February 05, 2026 has been entered.
Claim Status
2. Claims 1-2 and 19-21 are pending and under examination on the merits.
Claims 6-16 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made with traverse in the reply filed on March 14, 2025.
Claims 3-5 and 17-18 are cancelled.
Priority
3. The Office acknowledges receipt of Applicant’s foreign priority document Application No. JP2022-031815 filed on March 02, 2022. No certified English language translation of the foreign priority document has been received.
Information Disclosure Statement
4. The information disclosure statement (IDS) submitted on February 05, 2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered to the extent of the English translations provided.
Response to Arguments – Objections to the Specification
5. Applicant’s arguments and amendments filed February 05, 2026 have overcome the objections of record.
Response to Arguments – Claim Objections
6. Applicant’s arguments and amendments filed February 05, 2026 have overcome the objections of record. However, said amendments have necessitated new grounds of objection.
Claim 5 is cancelled; therefore, any objections and/or rejections to this claim are rendered moot.
Claim Objections
7. Claims 1-2 and 19-21 are objected to because of the following:
Claim 1 contains multiple typographical and/or grammatical errors that obscures the intended recitation. Does Applicant intend for the N-terminal structures recited in lns. 5-6 to be recited in the alternative? Are the amino acid positions comprising the N-terminus of SEQ ID NOs:3-4 variable? If not, it is suggested Applicant amend “or the N-terminal region of SEQ ID NO:4” to “and the N-terminal region of SEQ ID NO:4” in lns. 5-6. Likewise, it is suggested Applicant amend “or the C-terminal region of SEQ ID NO:4” to “and the C-terminal region of SEQ ID NO:4” in lns. 9-10, if appropriate. Regarding claim 1, lns. 6-7, it is recommended Applicant amend “95% sequence identity but is not identical with” to “95% sequence identity with but is not identical to” for grammatical clarity.
Dependent claims are included. Appropriate correction is required.
Response to Arguments – Claim Rejections - 35 USC § 112(b)
8. Regarding the rejection of claims 1-2 under 35 U.S.C. 112(b), Applicant’s arguments and amendments filed February 05, 2026 have overcome the rejections of record. However, said amendments have necessitated new grounds of rejection under 35 U.S.C. 112(b).
Claims 3-5 and 17-18 are cancelled; therefore, any objections and/or rejections to said claims have been rendered moot.
Claim Rejections - 35 USC § 112(b)
9. The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
10. Claims 1-2 and 19-21 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The metes and bounds of claim 1 are indefinite because the structure and sequence of the claimed mutant CPT protein is unclear. It is unclear how a protein that is SEQ ID NO:3 or SEQ ID NO:4 can comprise a mutation that distinguishes it from said sequence. The specification states that SEQ ID NOs:3-4 are amino acid sequences obtained from Arabidopsis thaliana and Hevea brasiliensis and therefore, are wildtype proteins[0265]. The relationship between SEQ ID NOs:3-4 and the claimed mutant CPT family protein is unclear. It is unclear if the claimed mutant CPT protein has the sequence of and is identical to SEQ ID NO:3/SEQ ID NO:4 or if the claimed mutant CPT protein has the sequence of some variation of SEQ ID NO:3/SEQ ID NO:4 comprising an undisclosed mutation within the recited N- and C-terminal residues. It is unclear if the claimed mutant CPT protein has or retains any features from SEQ ID NOs:3-4, because the claims do not require the recited mutant CPT protein comprise any of the N- and C-terminal residues of SEQ ID NO:3 or any of the N- and C-terminal residues of SEQ ID NO:4, only that the N- and C-termini each of the mutant protein have at least 95% sequence identity to the N- and C-termini, respectively, of a corresponding wild-type protein. It is recommended Applicant clarify which features, if any, of SEQ ID NOs:3-4 are retained in the claimed mutant CPT family protein. Unless the recited mutant CPT protein is identical to SEQ ID NO:3 or SEQ ID NO:4, it is recommended Applicant amend ln. 2 to recite that the mutant CPT protein comprises some degree of sequence identity to SEQ ID NO:3 or SEQ ID NO:4 to clarify the relationship between the claimed protein and SEQ ID NOs:3-4. Applicant is required to clarify the intended recitation.
The metes and bounds of claim 20 are undefined because the structure of the recited protein is unclear. It is unclear how the N-terminal region of a protein could be located downstream of the N-terminus because a region downstream of the N-terminus would not be located within the N-terminus. Any N-terminal region of a protein is/would be comprised within the N-terminus of the protein, wherein the recitation of “the N-terminal region” implies the entire N-terminus of the protein and the recitation of “an N-terminal region” would imply a partial sequence/region comprised within the N-terminus of said protein.
The metes and bounds of claim 21 are undefined because the structure of the recited protein is unclear. It is unclear how the C-terminal region of a protein could be located downstream of the C-terminus because a region downstream of the C-terminus would not be located within the C-terminus. Any C-terminal region of a protein is/would be comprised within the C-terminus of the protein, wherein the recitation of “the C-terminal region” implies the entire C-terminus of the protein and the recitation of “a C-terminal region” would imply a partial sequence/region comprised within the C-terminus of said protein.
Dependent claims are included. Appropriate correction is required.
Response to Arguments – Claim Rejections - 35 USC § 112(a)
11. Applicant’s arguments and amendments filed November 17, 2025 and February 05, 2026 have been fully considered but are not persuasive and do not overcome the rejections of record.
In the response dated November 17, 2025, Applicant argues that claims 3-5 have been cancelled and claims 1-2 have been amended to recite specific SEQ ID NOs and to further define the N-termini by amino acid positions (p. 03, “Issues under 35 USC § 112(a)”). Applicant reiterates this position in the response dated February 05, 2026 (p. 01, “Potential Issues Raised in Advisory Action”).
Applicant’s arguments are not persuasive because the claims remain broad and encompass mutations not described by the Applicant with sufficient detail or guidance to allow one of ordinary skill in the art to reproduce the claimed invention without undue experimentation and without any surprising or unexpected results.
As stated above, claim 1 is indefinite. For the purpose of compact prosecution, claim 1 is herein interpreted to encompass a mutant CPT protein wherein the N-terminal and C-terminal regions of the mutant CPT family protein have at least 95% sequence identity to the N-terminal and C-terminal regions of a wildtype CPT family protein, respectively, and wherein the mutant but not wildtype CPT family protein binds to a NgBR receptor. Though Applicant has narrowed the scope of the N-terminal and C-terminal regions of SEQ ID NOs:3-4, the claims do not require the claimed mutant CPT family protein share any features with SEQ ID NOs:3-4. Therefore, claim 1 remains broad and encompasses any CPT family protein wherein mutations/alterations to the sequence are limited to the N-terminal and C-terminal residues, wherein said mutation confers binding to NgBR, and the N-terminal and C-terminal residues have 95% sequence identity to a wildtype CPT family protein.
Because of one ordinary skill in the art could easily generate at least 72 mutant proteins by sequentially deleting a single amino acid residue from the N-terminus of SEQ ID NO:3 alone, claim 1 encompasses are large scope of sequences. However, Applicant describes only one mutant protein with the desired NgBR-binding function (e.g., an HRT1-AtCPT5 fusion protein)[0003], [0202], [0228-0229], [0230-0233]. Applicant does not describe any shared or conserved structures or features that confer said binding and one of skill in this art cannot envision the structure of any other sequences with the required function other than the few species provided by Applicant and the prior art. Furthermore, the claims are not limited to sequences obtained from SEQ ID NOs:3-4. When there is substantial variation within genera, as here in which the recitation of a mutant CPT family protein obtained by mutating any amino acid within the N-terminal and C-terminal regions of SEQ ID NO:3/SEQ ID NO:4, one must describe a sufficient variety of species to reflect the variation within the genera (see MPEP 2163). Therefore, since only a few species are provided to represent the genera, the claims encompassing the same fail the written description requirement.
Similarly, because neither the claims nor the specification provide sufficient guidance as to which regions and/or residues of the N- and C-termini of SEQ ID NOs:3-4 are sufficient or essential to confer binding to NgBR and unknown proteins comprising unknown mutations are not predictably functional. One of ordinary skill in the art could not predict, with any reasonable expectation of success, which residues within the N-terminus or C-terminus of SEQ ID NOs:3-4 can and/or must be mutated to confer binding to NgBR nor could one predict which residues must be retained to confer said binding without engaging in extensive and undue experimentation.
For the reasons described above, the rejections of the claims under the Written Description and Enablement requirements of 35 U.S.C. 112(a) are maintained.
Claims 3-5 and 17-18 have been cancelled; therefore, any objection and/or rejections to said claims have been rendered moot.
Claim Rejections - 35 USC § 112(a)
12. The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
Written Description
13. Claims 1-2 and 19-21 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claims contain subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
As discussed above in the rejection of the claims under 35 U.S.C. 112(b), claim 1 is indefinite. For the purpose of compact prosecution, claim 1 is herein interpreted to encompass any CPT family protein wherein mutations/alterations to the sequence are limited to the N-terminal and C-terminal residues, wherein the N-terminus and C-terminus of the mutant CPT protein has at least 95% sequence identity to the N-terminus and C-terminus, respectively, of a corresponding wild-type CPT protein, and wherein said mutation confers binding to NgBR. Therefore, claim 1 is broad and encompasses any and all insertions, deletions, and substitutions within any CPT family protein wherein the N-terminus and C-terminus of the mutant CPT protein has at least 95% sequence identity to the N-terminus and C-terminus, respectively, of a corresponding wild-type CPT protein, and wherein said mutation confers binding to NgBR. In fact, the claims do not require the recited mutant CPT protein comprise any of the residues of SEQ ID NO:3 or SEQ ID NO:4, only that the termini of the mutant protein have at least 95% sequence identity to the termini of a corresponding wild-type protein. Thus, claim 1 is broad and the recitations encompassing a mutant CPT obtained by mutating an amino acid sequence of the N-terminal and C-terminal regions of a CPT family protein lacks adequate written description.
Applicant suggests that the NgBR binding site of CPT family proteins is located within the N-terminus of the protein and discloses that the C-terminus of the protein affects the lengths of polyisoprenoids produced by said protein[0003], [0010]. Applicant further discloses the in vitro translation of a fusion protein encoded by a nucleic acid sequence comprising nucleotides 1-873 of HRT1 fused to nucleotides 217-909 of AtCPT5 and the in vitro synthesis of polyisoprenoids (rubber)[0003], [0202], [0228-0229], [0230-0233]. The state of the art teaches that CPT family proteins constitute a large family of enzymes with at least 79 distinct CPT family proteins present across all domains of life (Abstract; Fig. 3; Grabińska et al., Journal of Biological Chemistry. 2016; 291(35):18582-18590 (previously cited)). While the claims are effectively drawn to any mutant CPT protein wherein the protein comprises an N-terminal and C-terminal region that has at least 95% sequence identity to the N-terminus and C-terminus, respectively, of any wildtype CPT family protein and binds NgBR, the only NgBR-binding structure provided by Applicant is the previously mentioned HRT1-AtCPT5 fusion protein. However, one ordinarily skilled in the art could make at least 151 variants of AtCPT5 alone by generating variants comprising a mutation deletion any one of amino acid residues 1-151 of AtCPT5. The claims’ requirement that the mutant protein bind to NgBR, does not clarify the structure of the protein because Applicant does not describe any conserved regions of the fusion protein that are sufficient or required to confer binding to NgBR. Thus, the specification does not describe species over the full scope of the claimed protein sequences.
MPEP § 2163 states that the written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or
disclosed correlation between function and structure, or by a combination of such identifying
characteristics, sufficient to show the applicant was in possession of the claimed genus. A
“representative number of species” means that the species which are adequately described are
representative of the entire genus. Thus, when there is substantial variation within genera, as here in which the recitation of a mutant CPT family protein obtained by mutating an amino acid
sequence of a N-terminal region of the CPT family protein, one must describe a sufficient variety
of species to reflect the variation within the genera. One of skill in this art cannot envision the structure of any other sequences with the required function other than the few species provided by Applicant and the prior art. Therefore, since only a few species are provided to represent the genera, the claims encompassing the same clearly fail the written description requirement. Accordingly, there is lack of adequate description to inform a skilled artisan that Applicant was in possession of the claimed invention at the time of filing.
Claims 2 and 19 provide the further limitation that the N-terminus and C-terminus of the mutant protein retain at least 98% sequence identity (claim 2) and 99% sequence identity (claim 19) to any wild-type CPT family protein. However, these additional limitations are not sufficient to overcome the deficiency regarding a mutant CPT obtained by a mutating an amino acid sequence of an N-terminal and C-terminal region of a CPT family protein to confer binding to NgBR.
Claims 20-21 are indefinite for the reasons described above in the rejection of the claims under 35 U.S.C. 112(b). Accordingly, any additional limitations required by claims 20-21 are not sufficient to overcome the deficiency regarding a mutant CPT obtained by a mutating an amino acid sequence of an N-terminal and C-terminal region of a CPT family protein to confer binding to NgBR.
Accordingly, there is lack of adequate description to inform a skilled artisan that Applicant was in possession of the claimed invention at the time of filing.
Enablement
14. Claims 1-2 and 19-21 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a mutant CPT protein encoded by a nucleic acid sequence comprising nucleotides 1-873 of HRT1 fused to nucleotides 217-909 of AtCPT5, does not reasonably provide enablement for all mutant CPT proteins wherein the mutant CPT protein comprises any CPT family protein wherein the N-terminus and C-terminus of the mutant CPT protein has at least 95% sequence identity to the N-terminus and C-terminus, respectively of a corresponding wild-type CPT protein and wherein the mutant CPT family protein binds to NgBR. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to produce the invention commensurate in scope with these claims.
When determining whether a claimed invention complies with the enablement requirement, factors to consider include: “(1) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims.” Id.
Applicant’s disclosure is as set forth above. The claimed invention is not enabled for the following reasons.
Applicant has not provided sufficient guidance for one of ordinary skill in the art to predict which mutant CPT family proteins encompassed by a CPT family protein obtained by mutating an amino acid sequence of the N-terminal and C-terminal region of a CPT family protein such that the N-terminus and C-terminus of the mutated protein has at least 95% sequence identity to the N-terminus and C-terminus, respectively, of a wildtype CPT protein would form functional enzymes capable of binding NgBR.
As stated above in the Written Description-based rejections of the claims under 35 U.S.C.
112(a), claim 1 is broad and encompasses any and all insertions, deletions, and substitutions in any CPT family protein wherein the mutant CPT protein has at least 95% sequence identity to the N-terminus and C-terminus of corresponding wild-type CPT proteins, and wherein said mutation confers binding to NgBR. However, Applicant discloses only one working example of a CPT family protein comprising mutations within the N-terminal region of the protein[0228-0229]. The state of the art teaches that protein chemistry is one of the most unpredictable areas of biotechnology. For example, substitution of Tyr-38 of growth factor α with Phe or Trp did not abolish protein activity while replacement of Tyr-38 with Ala, Ser, His, or Thr severely reduced or abolished protein activity (Lazar et al., Molecular and Cellular Biology, 1989; 9(2):860-864 (previously cited)).
Together, these examples teach that the effect of a single amino acid change on protein function is unpredictable. Though the state of the art teaches several highly conserved amino acid regions among various CPT family proteins (Fig. 4; Grabińska et al., Journal of Biological Chemistry. 2016; 291(35):18582-18590 (previously cited)), the art does not disclose what impact mutating these residues has on the function of each specific CPT family protein. Furthermore, Applicant does not disclose the structure or sequence of the claimed CPT family protein. Accordingly, one of ordinary skill in the art cannot predict what impact unknown mutations will have on unknown enzymes. Thus, unknown CPT family proteins comprising unknown amino acid substitutions, truncations, or insertions within the N-terminus and C-terminus of the protein(s) are not predictably functional, and so are not enabled.
Claims 2 and 19 add further limitations in requiring the structure of the N-terminus and C-terminus of the mutant protein retain at least 98% (claim 2) or 99% (claim 19) sequence identity to a wildtype CPT family protein. However, Applicant does not describe which regions of the N-terminus and C-terminus are essential or sufficient for binding to NgBR and unknown CPT family proteins comprising unknown mutations are not predictably functional. Therefore, claims 2 and 19 are not enabled.
Claims 20-21 are indefinite for the reasons described above in the rejection of the claims under 35 U.S.C. 112(b). Accordingly, any additional limitations required by claims 20-21 are not sufficient to overcome the deficiency regarding a mutant CPT obtained by a mutating an amino acid sequence of an N-terminal and C-terminal region of a CPT family protein to confer binding to NgBR. Therefore, claims 20-21 are not enabled.
In making this determination, the Office has weighed each of the Wands factors. The breadth of the claims is to CPT family protein comprising mutations within the N-terminus and C-terminus of the protein to allow binding to NgBR. The nature of the invention comprises an enzyme capable of synthesizing rubber/polyisoprenoids. The level of skill in the plant biotechnology art is high. The state of the prior art does not teach the N-terminus and C-terminus of CPT family proteins as dispensable to enzymatic function. Applicant provides only one working example of a mutant CPT family protein comprising mutations within the N-terminus and C-terminus of the protein. Given these difficulties, notwithstanding the relatively high level of ordinary skill of those in the art, the amount of experimentation would likely be extensive and undue. Weighing all of the Wands factors based on the totality of the record as discussed above, the Office determines that it would require undue experimentation for a person of ordinary skill in the art to make and use the invention as claimed.
Accordingly, the claims are not enabled.
Response to Arguments – Double Patenting
15. Applicant’s arguments and amendments filed November 17, 2025 and February 05, 2026 have been fully considered but are not persuasive and do not overcome the rejections of record. Furthermore, Applicant’s amendments filed February 05, 2026 have necessitated new grounds of rejection for the newly presented claims 19-20.
Applicant traverses the rejections and requests reconsideration of the claims in view of the present amendments but does not clearly state or explain the grounds of traversal. Applicant does not provide a clear argument explaining if and/or how the previously and/or currently presented claims differ from the art of record. Applicant’s arguments are not persuasive because Applicant does not specify which, if any, features the prior art allegedly fails to disclose.
Accordingly, the claims remain rejected on the grounds of nonstatutory double patenting as being unpatentable over claims of copending Application No. 18/164,700 in view of Liang et al. (European Journal of Biochemistry. 2002; 269(14):3339-3354 (previously cited)).
Claims 3-5 and 17-18 have been cancelled; therefore, any objection and/or rejections to said claims have been rendered moot.
Double Patenting
16. The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
17. Claims 1-2 and 19-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 and 17-18 of copending Application No. 18/164,700 in view of Liang et al. (European Journal of Biochemistry. 2002; 269(14):3339-3354 (previously cited)). Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding instant claim 1, claim 1 of co-pending Application No. 18/164,700 recites a mutant CPT family protein comprising a mutation in an amino acid sequence of a N-terminal region of a CPT family protein wherein said mutant protein binds NgBR and wherein the N-terminal region of the mutant CPT family protein has at least 95% sequence identity to a wildtype CPT family protein.
Claim 1 of Application co-pending No. 18/164,700 is silent to but does not exclude mutations within a C-terminal region of the CPT family protein.
Liang teaches a mutant CPT family protein obtained by mutating an amino acid sequence of an N-terminal region and C-terminal region of said protein (p. 3343, right column, first full paragraph).
One of ordinary skill in the art would be motivated to produce a CPT family protein comprising mutations in both the N- and C-terminus of the protein and it would have been prima facie obvious to do so, because Liang teaches that mutations of N-terminal and C-terminal amino acids within the hydrophobic tunnel of the E. coli UPPS results in the generation of 60-, 65-, and 70-carbon chain-length products in comparison to the 55-carbon product generated by the wildtype enzyme (Liang, p. 3344, “Mechanism of product chain-length determination in cis-IPPS”). Accordingly, one of ordinary skill in the art would have been motivated to produce the claimed invention with a reasonable expectation of success and without any surprising results (see the rejection of claim 1 under 35 U.S.C. 103 for further detail). Because claim 1 of co-pending Application No. 18/164,700 also encompasses CPT family proteins further comprising mutations within a C-terminal region, instant claim 1 is unpatentable over claim 1 of co-pending Application No. 18/164,700 in view of Liang.
Regarding instant claim 2, claim 2 of co-pending Application No. 18/164,700 further recites a mutation wherein the N-terminal region of the CPT family protein shares at least 98% sequence identity with a wildtype CPT protein. Instant claim 2 requires the claimed protein share at least 98% sequence identity to a wildtype protein in both its N-terminal and C-terminal regions. Because claim 2 of co-pending Application No. 18/164,700 encompasses CPT family proteins further comprising mutations within a C-terminal region, instant claim 2 is unpatentable over claim 2 of co-pending Application No. 18/164,700 in view of Liang.
Regarding instant claim 19, claim 19 of co-pending Application No. 18/164,700 further recites a mutation wherein the N-terminal region of the CPT family protein shares at least 99% sequence identity with a wildtype CPT protein. Instant claim 2 requires the claimed protein share at least 99% sequence identity to a wildtype protein in both its N-terminal and C-terminal regions. Because claim 2 of co-pending Application No. 18/164,700 encompasses CPT family proteins further comprising mutations within a C-terminal region, instant claim 2 is unpatentable over claim 2 of co-pending Application No. 18/164,700 in view of Liang.
Regarding instant claim 20, the claim is indefinite for the reasons described above in the rejection of the claims under 35 U.S.C. 112(b). Similarly, claim 18 of copending Application No. 18/165,026 also recites an N-terminal amino acid sequence that is impossibly downstream of the N-terminus of the mutant CPT family protein. Accordingly, instant claim 20 is anticipated by claim 18 of copending Application No. 18/165,026.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments – Claim Rejections - 35 USC § 101
18. Applicant’s arguments and amendments filed November 17, 2025 and February 05, 2026 have overcome the rejections of record.
Claims 3-5 and 17-18 have been cancelled; therefore, any objection and/or rejections to said claims have been rendered moot.
Conclusion
19. No claim is allowed. The closest prior art, Yamaguchi et al. (US-2023/0167465-A1,
published 06/01/2023, filed 02/22/2021 (previously cited)), teaches a mutant CPT family protein
wherein the mutant CPT protein comprises a truncation mutation at a N-terminal region[0080-0081] (Fig. 3) and wherein the C-terminal region comprises a substitution mutation[0014], [0102-0106]. However, Yamaguchi does not teach a mutant CPT family protein that binds NgBR.
Examiner’s Contact Information
20. Any inquiry concerning this communication or earlier communications from the examiner should be directed to DEQUANTARIUS J SPEED whose telephone number is (703)756-4779. The examiner can normally be reached M-F; 9AM-5PM ET.
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/DEQUANTARIUS JAVON SPEED/Junior Examiner, Art Unit 1663
/Amjad Abraham/SPE, Art Unit 1663
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